Long Term Vascular Changes in Type 1 Diabetes (DM09)
| Tracking Information | |||||
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| First Received Date ICMJE | October 7, 2009 | ||||
| Last Updated Date | October 7, 2009 | ||||
| Start Date ICMJE | April 2009 | ||||
| Estimated Primary Completion Date | April 2010 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Fatal and non fatal cardiovascular disease (CVD) and stroke [ Time Frame: One year ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | No Changes Posted | ||||
| Current Secondary Outcome Measures ICMJE |
Vessel area stenosis [ Time Frame: One year ] [ Designated as safety issue: Yes ] | ||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Long Term Vascular Changes in Type 1 Diabetes | ||||
| Official Title ICMJE | Long Term Vascular Changes in Type 1 Diabetes, Clinical Aspects and Biological Markers | ||||
| Brief Summary | The main purpose of this study is to investigate progression of late complications of diabetes during the last ten years in a well characterized cohort of type 1 diabetes with a long duration of the disease, and to define factors responsible for the progression of late complications. |
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| Detailed Description | Despite intensively research in the field of hyperglycaemia and coronary heart disease in type 1 diabetes it is still not known in detail how hyperglycaemia leads to damage of the vessels. The aims of the present proposal are therefore two-fold:
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| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Retention: Samples With DNA Description: whole blood, serum, white cells, urine, tissue |
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| Sampling Method | Probability Sample | ||||
| Study Population | This project will be a continuation of the previous cohort performed originally from 1982. The group or cohorts will be selected from primary care clinic. |
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| Condition ICMJE |
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| Intervention ICMJE | Not Provided | ||||
| Study Group/Cohort (s) | Diabetes, type 1 | ||||
| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Enrolling by invitation | ||||
| Estimated Enrollment ICMJE | 45 | ||||
| Estimated Completion Date | May 2010 | ||||
| Estimated Primary Completion Date | April 2010 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | The original criteria from 1982: Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 40 Years to 70 Years | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Norway | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00991575 | ||||
| Other Study ID Numbers ICMJE | 916501, S-08843c/21262 | ||||
| Has Data Monitoring Committee | Yes | ||||
| Responsible Party | Kristian F. Hanssen, Professor MD, Oslo University hospital | ||||
| Study Sponsor ICMJE | Oslo University Hospital | ||||
| Collaborators ICMJE | University Hospital, Aker | ||||
| Investigators ICMJE |
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| Information Provided By | Oslo University Hospital | ||||
| Verification Date | October 2009 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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